(Photo © Osstem Implant )
Osstem Implant, one of the world’s leading manufacturers of dental implants, adopted the 3DEXPERIENCE platform from Dassault Systèmes and the industry solution License to Cure for Medical Device to accelerate the delivery of innovative, safe, and fully compliant medical devices with international regulations. The goal: to combine customization, quality, and regulatory compliance without slowing innovation.
Innovation for a healthy smile
Founded in 1997, Osstem Implant is a leader in the Asia-Pacific dental implant sector, with a strong presence in Korea and China, ranking among the world’s top five manufacturers. Its competitiveness is based on a strong commitment to R&D and advanced ultra-precision machining technologies, surface treatments, and strict quality controls.
The dental market requires a wide variety of implants tailored to each patient’s specific characteristics: ultra-wide implants, short implants, or customized abutments. To address this diversity, the company needed a flexible and robust information management infrastructure capable of adapting to the growing demand for customization without compromising efficiency.
Regulatory compliance without slowing development
Global growth involves complying with demanding national and international regulations. In particular, implementing the UDI (Unique Device Identification) system in accordance with the FDA was a key step in improving traceability and patient safety.
However, although Osstem Implant was already generating and submitting UDI information to the FDA’s GUDID database, this data was not connected to design information or internal quality processes. This made it difficult to track issues in case of errors and slowed down the generation of new identifiers for its wide range of products.
The company needed a solution capable of integrating design, quality, regulation, and production within a unified environment.
(Photo © Osstem Implant)
3DEXPERIENCE and License to Cure: end-to-end integration
To globally manage UDI information, design changes, and quality processes, Osstem Implant chose the 3DEXPERIENCE platform and the License to Cure for Medical Device solution, specifically developed for the life sciences sector.
This solution provides a collaborative and integrated framework that connects product development data with quality and regulatory information in a single updated source. It also supports ISO-regulated design controls and the submission of UDI information to the FDA through the HL7 SPL standard.
After its implementation, processes that were previously managed in isolation became fully integrated: bill of materials (BOM) management, device master record (DMR), document control and versioning, requirements, certifications, environmental substances, and especially UDI management.
Traceability, quality, and agile response
Integrating UDI within the 3DEXPERIENCE environment significantly improved quality control. It is now possible to quickly trace the Device Identifier (DI) and the Production Identifier (PI) simply by consulting the product’s UDI.
This enables a faster response to potential incidents, improves patient safety, and strengthens post-market device surveillance. In addition, the company has an infrastructure that fosters collaboration among quality, production, licensing, and R&D departments.
Thanks to the platform, Osstem Implant has improved operational efficiency, accelerated time-to-market, and strengthened regulatory compliance, thus advancing toward its strategic vision: becoming the world’s number one manufacturer of dental implants.
Article based on the customer story published by Dassault Systèmes on its official website.
Access the full case here: https://www.3ds.com/insights/customer-stories/osstem-implant
About Osstem Implant
Manufacturer of dental medical devices.
Products: dental implant solutions, dental materials, and pharmaceutical products.
Headquarters: Seoul, South Korea.
More information: www.osstem.com
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